Enhancement of Residual Limb Proprioception and Rehabilitation Training Methods With a Vibrotactile Device.

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
California State University, Long Beach
California State University, Dominguez Hills
Information provided by (Responsible Party):
Dana Craig, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT02026570
First received: December 19, 2013
Last updated: April 25, 2016
Last verified: April 2016
  Purpose

Objectives: The purpose of this study is to investigate attentional (internal vs. external) focus effects on persons with amputation to perform a defined compensatory movement to reduce the likelihood of a fall. An internal focus of attention directs a person's conscious attention to their body's movements, whereas an external focus of attention directs a person's conscious attention to the effects of their movements or specific features in the environment. Numerous experiments have investigated the effects of an internal and external focus of attention on motor performance and the findings are in favor of an external focus of attention. In our work, we propose a motor learning research experiment to evaluate attentional focus strategies on the rehabilitation outcomes of learning and adaptation to the new proprioceptive information for persons with a recent transtibial amputation.

Research Design and Methodology: For this pilot study, six participants with recent unilateral transtibial amputation will be recruited. Four participants will receive internal and external focus of attention training methods while the other two (control group) will receive standard prosthetic training instructions. The experiment will be conducted in three phases: Phase 1 -- Baseline Performance Test, Phase 2 -- Training sessions, and Phase 3 - Learning Test. The training will utilize a vibrotactile device designed to generate tactile sensations at the skin-socket interface simulating contact of the prosthesis with the environment. The sensation simulates a perturbation that signals a potential fall event. During the experiment the augmented sensory information will be introduced randomly while participants walk at a preferred pace on a level surface. Movement kinematics and kinetics of the body will be recorded for analyses using a motion capture system with force plates.

Finding: It is hypothesized that the external focus of attention condition will outperform the internal focus of attention condition when responding to perturbations. The external focus of attention condition will yield faster response time and show improved compensatory responses compared to the internal focus of attention group by producing a greater lateral displacement of the artificial limb relative to the line of progression. In addition, the external condition will demonstrate a greater step length and step height than the internal focus of attention condition when provided with a perturbation.

Clinical Significance: Current practices within the field of Physical Therapy reveal that there is little therapeutic intervention for fall prevention. Instructions are traditionally provided on how to reduce the risk of falling through preparation of a room or obstacle avoidance or on the proper way to fall to decrease injury. However, there are no protocols for providing a prosthetic user with compensatory strategies to avoid a fall after a perturbation occurs. The research findings can result in improved training protocols, which can improve rehabilitative outcome.

Impact/Significance: The growing number of prosthetic users presents a need for improved patient care and effective prosthetic training and rehabilitation methods. Complimentary to the mission of the VA, the results of this research could enhance the quality of patient care and further assist these patients toward becoming prosthetically rehabilitated.


Condition Intervention
Transtibial Amputation
Behavioral: Internal Focus of Attention
Behavioral: External Focus of Attention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Enhancement of Residual Limb Proprioception and Rehabilitation Training Methods With a Vibrotactile Device.

Resource links provided by NLM:


Further study details as provided by Southern California Institute for Research and Education:

Primary Outcome Measures:
  • Reaction Time [ Time Frame: Five visits over a three week period. ] [ Designated as safety issue: No ]
    Time for subject to laterally displace Center of Mass two standard deviations from normative trajectory following stimulus.


Secondary Outcome Measures:
  • Movement Time [ Time Frame: Five visits over a three week period. ] [ Designated as safety issue: No ]
    Time from reaction time to completion of task, which is a side step following stimulus.


Estimated Enrollment: 6
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Persons with unilateral transtibial amputation receiving standard physical therapy.
Experimental: Motor Control Internal Focus
Persons with unilateral transtibial amputation receiving standard physical therapy and additional training with motor control internal focus of attention instructions.
Behavioral: Internal Focus of Attention
Providing instructions for the user to manipulate their residual limb in space during standing and walking tasks.
Experimental: Motor Control External Focus
Persons with unilateral transtibial amputation receiving standard physical therapy and additional training with external focus of attention instructions.
Behavioral: External Focus of Attention
Providing instructions for the user to manipulate their prosthetic foot in space during standing and walking tasks.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergone amputation within the past year.
  • Currently undergoing prosthetic training in Physical Therapy utilizing a prosthesis.
  • Be within two weeks of completing prosthetic training in Physical Therapy.
  • Ability to tolerate walking for a minimum of 100 yards over the course of a four hour time period with or without resting.
  • No current skin breakdown on the residual limb.

Exclusion Criteria:

  • Not cleared by Physical Therapy to use the prosthesis without contact precautions.
  • Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026570

Locations
United States, California
V.A. Long Beach Healthcare System
Long Beach, California, United States, 90822
Sponsors and Collaborators
Southern California Institute for Research and Education
California State University, Long Beach
California State University, Dominguez Hills
Investigators
Principal Investigator: Dana D. Craig, M.A. V.A. Long Beach Healthcare System
  More Information

Publications:
D. J. DiLorenzo, D. J. Edell, M. J. Koris, and R. R. Riso, "Chronic intraneural electrical stimulation for prosthetic sensory feedback," 1st IEEE EMBS Conference on Neural Engineering, pp:116-119, 2003.
G.E. Loeb and F.J. Richmond. BION Implants for Therapeutic and Functional Electrical Stimulation. Neural Prostheses for Restoration of Sensor and Motor Function. CRC Press, Boca Raton, FL, 2000. R.A. Magill. "Motor Learning and Control: Concepts and Applications," (9th ed.). New York, NY: McGraw Hill, 2011
J.A. Sabolich and G.M. Ortega. "Sense of feel for lower-limb amputees: A phase-one study," Journal of Prosthetics and Orthotics, 6(2):36-41, 1994
J.A. Sabolich, G.M. Ortega, and G.B. Schwabe. "System and method for providing a sense of feel in a prosthetic or sensory impaired limb," United States Patent, December 31, 2002
D.C. Simpson. "The choice of control system for the multimovement prosthesis: extended physiological proprioception (EPP), " In: The Control of Upper-Extremity Prostheses and Orthoses. Springfiled, Illinois, C.C Thomas. pp:146-150, 1974
D.C. Simpson. "The control and supply of a multimovement externally powered upper limb prosthesis," Proc 4th Ini Symp External Control of Human Extremities. Belgrade, Yugoslav Committee for Electronics and Autotlon. pp:247-254, 1973
D. Zambarbieri, M. Schmid, and G. Verni. "Sensory feedback for lower limb prosthesis", in Intelligent Systems and Technologies in Rehabilitation Engineering, Ed. H.L. Teodorescu and L. Jain, CRC Press, Boca Raton, 2001

Responsible Party: Dana Craig, Health System Specialist, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT02026570     History of Changes
Other Study ID Numbers: 01234 
Study First Received: December 19, 2013
Last Updated: April 25, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Southern California Institute for Research and Education:
Prosthesis
Falls
Training

ClinicalTrials.gov processed this record on August 23, 2016